Study of CC-5013 to Evaluate Safety, Pharmacokinetics and Effectiveness for Japanese Patients With Symptomatic Anemia Associated With Myelodysplastic Syndrome With a Del(5)(q31-33) Abnormality.
This study has been completed.
Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00812968
First received: December 17, 2008
Last updated: September 13, 2012
Last verified: September 2012
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Purpose
The purpose of this clinical experience study is to determine whether CC-5013 is safe and effective (to include studying the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body [pharmacokinetics]) in Japanese subjects with low- or intermediate-1-risk MDS (IPSS risk categories) associated with a deletion 5(q31-33) abnormality and symptomatic anemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndromes |
Drug: Lenalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Single-arm Study to Assess the Safety, Pharmacokinetics and Efficacy of Lenalidomide in Japanese Subjects With Low- or Intern=Mediate-1-risk Myelodysplastic Syndromes (MDS) Associated With a Deletion 5 (q31-33) Abnormality and Symptomatic Anemia |
Resource links provided by NLM:
Further study details as provided by Celgene Corporation:
Primary Outcome Measures:
- Adverse events [ Time Frame: Approximately 3 years ] [ Designated as safety issue: Yes ]Number of participants with adverse events
Secondary Outcome Measures:
- PK-(Cmax) [ Time Frame: Days 1 and 4 ] [ Designated as safety issue: No ]Maximum observed concentration in Plasma (Cmax)
- PK-(Tmax) [ Time Frame: Days 1, 2, 4 and 5 ] [ Designated as safety issue: No ]Time to maximum concentration in plasma
- PK-(AUC) [ Time Frame: Days 1, 2, 3,4 and 5 ] [ Designated as safety issue: No ]Area under the plasma concentration-time curve
- PK-(T1/2) [ Time Frame: Days 1, 2, 4 and 5 ] [ Designated as safety issue: No ]Terminal half-life (T1/2)
- Pk-(Vz/f) [ Time Frame: Days 1, 2, 3, 4 and 5 ] [ Designated as safety issue: No ]Apparent volume of distribution
- PK-(CL/f) [ Time Frame: Days 1, 2, 3, 4 and 5 ] [ Designated as safety issue: No ]Oral clearance
- PK-(λz) [ Time Frame: Days 1, 2, 3, 4 and 5 ] [ Designated as safety issue: No ]Apparent terminal elimination rate constant
- Erythroid Response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Major and Minor erythroid response based on the International Working Group Criteria for measurement of Response/Treatment Effect
- Change in hemoglobin [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]change of blood hemoglobin concentration from baseline in subjects who achieve an erythroid response
- Neutrophil Response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Major and minor neutrophil response based on the International Working Group Criteria for Measurement of Response/Treatment Effect
- Platelet Response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Major and minor erythroid response based on the International Working Group Criteria for Measurement of Response/Treatment Effect
- Cytogenetic Response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Cytogenetic response based on the International Working Group Criteria for Measurement of Response/Treatment Effect
- Bone Marrow Response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Bone marrow response based on the International Working Group Criteria for measurement of Response/Treatment Effect
| Enrollment: | 11 |
| Study Start Date: | September 2007 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lenalidomide
Oral 10mg daily on Days 1-21 days every 28 days until disease progression/relapse or CC-5013 is permanently discontinued for any reason for up to 156 weeks (3 years).
|
Drug: Lenalidomide
Oral 10mg daily on Days 1-21 days every 28 days until disease progression/relapse or CC-5013 is permanently discontinued for any reason for up to 156 weeks (3 years).
Other Names:
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must understand and voluntarily sign an informed consent form.
- Age ≥ 20 years at the time of signing the informed consent form.
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Diagnosis of Myelodysplastic Syndrome (MDS) that meets International Prognostic Scoring System (IPSS) criteria for low- or intermediate-1-risk disease associated with a deletion 5(q31-33) abnormality
- Symptomatic anemia secondary to MDS defined as:Untransfused Hb level < 10.0 g/dL and a Functional Assessment of Cancer Therapy (FACT)-anemia subscale score of ≤ 74 or Transfusion dependent anemia
Exclusion Criteria:
- Pregnant or lactating females.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Prior therapy with lenalidomide.
- Patients with any of the following laboratory abnormalities within 14 days of starting study drug: Absolute Neutrophil Count (ANC) < 750 cells/μL (0.75 x 10^9/L) Platelet count < 50,000/μL (50x10^9/L) Serum creatinine > 2.5 mg/dL Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3.0 x Upper Limit of Normal (ULN)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812968
Locations
| Japan | |
| Celgene Clinical Site | |
| Shimono, Tochigi, Japan, 329-0498 | |
| Celgene Clinical Site | |
| Shibuya-ku, Tokyo, Japan, 150-8935 | |
| Celgene Clinical Site | |
| Hiroshima, Japan, 734-8551 | |
| Celgene Clinical Site | |
| Kyoto, Japan, 601-1495 | |
| Celgene Clinical Site | |
| Osaka, Japan, 543-8555 | |
| Celgene Clinical Site | |
| Shizuoka, Japan, 420-8527 | |
Sponsors and Collaborators
Celgene Corporation
Investigators
| Study Director: | Masaaki Takatoku, MD | Celgene Corporation |
More Information
No publications provided by Celgene Corporation
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00812968 History of Changes |
| Other Study ID Numbers: | CC-5013-MDS-007 |
| Study First Received: | December 17, 2008 |
| Last Updated: | September 13, 2012 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Celgene Corporation:
|
Myelodysplastic Syndromes Lenalidomide |
Additional relevant MeSH terms:
|
Congenital Abnormalities Myelodysplastic Syndromes Preleukemia Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms Lenalidomide Thalidomide Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013